July 29, 2025, 3:42 pm | Read time: 3 minutes

According to the U.S. Food and Drug Administration (FDA), potential buyers should currently steer clear of fitness trackers from Whoop. In the worst-case scenario, using them could endanger your health.

Whoop Fitness Trackers Under Scrutiny

The Food and Drug Administration (FDA) recently issued a warning about Whoop fitness trackers. The agency cites a feature that, in its current form, violates existing laws and poses a health risk. They demand its immediate discontinuation.

In the letter addressed to Whoop CEO Will Ahmed, the FDA highlights the “Blood Pressure Insights” (BPI) feature. This feature is designed to provide users with insights into their blood pressure by sending daily estimates of systolic and diastolic blood pressure. However, a paid subscription is required, as stated on the Whoop website.

Since blood pressure measurement is directly related to diagnosing hypo- and hypertension, the feature and thus the Whoop fitness trackers are considered medical products. Such products require approval, which, according to the FDA, is not in place.

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Whoop Fights Back

As reported by “NBC New York,” Whoop has already responded. The manufacturer disputes the classification as a medical product and emphasizes that they collect blood pressure data solely to provide performance and wellness insights. The company believes the FDA is overstepping its authority.

They also point out that other health data, such as respiratory or heart rate, are already permissible in a wellness context. However, Whoop has already received FDA clearance for an ECG function. Other manufacturers, such as Garmin, also incorporate blood pressure functions into their products, for which they have FDA approval.

According to the report, Whoop has 15 days to respond to the FDA’s demands and present steps to resolve the issue.

Official Statement from Whoop

Whoop also sent TECHBOOK an official statement, which reads as follows:

“WHOOP transforms cutting-edge research into practical tools to enhance human performance.

Blood Pressure Insights was developed to give our members a better understanding of how blood pressure relates to sleep, stress, recovery, and exercise. Recent statements by the FDA, suggesting that Blood Pressure Insights must be classified as a medical device, fail to recognize that this feature is a wellness tool not intended for diagnosing or treating diseases.

This interpretation also contradicts the 21st Century Cures Act, which clarifies that features intended to promote a healthy lifestyle—and not aimed at diagnosing, curing, mitigating, preventing, or treating a disease or condition—are not considered medical devices.

We developed Blood Pressure Insights based on rigorous data validation and peer-reviewed research to provide our members with information about their bodies and enhance their performance. During the rollout and through app notifications, members are clearly informed that Blood Pressure Insights is not intended for medical decisions and is not a substitute for clinical devices for diagnosing or treating health conditions.

WHOOP members have always been at the forefront of using data to optimize performance. Heart rate, heart rate variability (HRV), recovery score, stress score, respiratory rate, and many other metrics help Americans better understand their well-being and improve their performance. Blood Pressure Insights continues this tradition. Our members are already finding ways to live and train better.

We stand by Blood Pressure Insights and believe our members should have access to information about their bodies.”

^{Official Statement from Whoop}